Friday, 30 October 2020

Dupixent show sustained improvement in lung function in asthma patients

08 September 2020 | News

With more than 2,200 patients enrolled, Phase 3 open-label extension trial is the largest of a biologic medicine ever conducted in asthma

Image source: Shutterstock

Image source: Shutterstock

Regeneron Pharmaceuticals and Sanofi recently announced new results from a Dupixent® (dupilumab) Phase 3 open-label extension trial that showed the safety and efficacy profile observed in previous Dupixent trials was maintained for up to three years in adults and adolescents with moderate-to-severe asthma. Data from the trial will be presented during a live session at the virtual 2020 European Respiratory Society (ERS) International Congress.

The analyses to be presented at ERS included more than 2,200 patients who previously participated in Dupixent asthma trials, including three pivotal trials that lasted between 24 and 52 weeks. Patients entered the extension trial after finishing active treatment or placebo in the initial trials and were treated for up to an additional two years, providing up to three years of treatment data in total.

Results showed:

  • Patients continued to experience improvement in lung function by 13-22% at 96 weeks, as measured by the average change in forced expiratory volume over one second (FEV1) compared to baseline for the initial asthma trials.
  • Patients maintained a low rate of severe asthma attacks with an average of 0.31-0.35 events per year. 
  • Improvements in lung function and asthma attacks were greater in those with elevated baseline blood eosinophils or fractional exhaled nitric oxide (FeNO), which are markers of type 2 inflammation. Patients showed reductions in blood eosinophils (23-35%) and in blood IgE for patients from the pivotal Phase 2b trial (82%) compared to baseline for the initial asthma trials.
  • The proportion of patients with adverse events (AEs) in the open label extension trial was similar to that seen in prior pivotal trials of Dupixent in asthma. 

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